The Efficacy of TARGET Model in Reducing Anxiety Symptoms and Correlates of Trauma among Women with Anxiety Disorders who had histories of Childhood Trauma
Determining the efficacy of TARGET on reducing anxiety symptoms and trauma correlates in people with anxiety disorders with a history of childhood trauma
Design
A randomized clinical trial with one experimental group and a control group; semi-experimental; with 40 participants, each group including 20 patients. Online randomization will be done via www.graphpad.com/quickcals
Settings and conduct
Among those who visit two Psychiatric Offices from Aug 22, 2020, to Dec 20, 2020, patients with anxiety disorders fill out the Childhood Trauma screening tool. The researcher does not distribute the forms (but the office secretary). People enter the study if they have the necessary criteria. The 10-session intervention phase is performed then. The posttest phase is within 2 weeks later and there is a 2-month follow-up.
Participants/Inclusion and exclusion criteria
The inclusion criteria: Female gender; Diagnosed with an anxiety disorder, moderate to severe, based on the Spielberger Anxiety Questionnaire scores on State or Traite anxiety (score 20-53); History of childhood trauma based on the Childhood Trauma Questionnaire;
The exclusion criteria: Evidence of cognitive impairments (orientation, attention, and impaired memory in Mini–mental state examination); ُُSevere mental disorders, such as schizophrenia and bipolar disorder, according to the psychiatrist's diagnosis
Intervention groups
The experimental group is the patients who are undergoing medications and TARGET group psychotherapy at the same time; and the control group is patients who are treated only by medications as Treatment As Usual.
Main outcome variables
Anxiety; Depression; Post-traumatic cognitions; Coping strategies; Difficulties in Emotion Regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191230045947N1
Registration date:2020-07-19, 1399/04/29
Registration timing:prospective
Last update:2020-07-19, 1399/04/29
Update count:0
Registration date
2020-07-19, 1399/04/29
Registrant information
Name
Narges Barzgar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0045
Email address
narkises73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of TARGET Model in Reducing Anxiety Symptoms and Correlates of Trauma among Women with Anxiety Disorders who had histories of Childhood Trauma
Public title
TARGET Efficacy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of childhood trauma
suffering from an anxiety disorder
Severity of anxiety ranging from 20 to 53 in Spielberger Anxiey Questionnaire
Informed Consent
Female gender
ages 18 to 65
Exclusion criteria:
Having severe mental disorders including Schizophrenia spectrum and Bipolar; Antisocial, Borderline, Paranoid, and Schizotypal Personality Disorders
Having severe personality disorders including antisocial, borderline, paranoid, and schizotypal personality disorders
Evidence of cognitive impairments (orientation, attention, and impaired memory in Mini–mental state examination- MMSE)
Hospitalization in a psychiatric hospital in the last month
Participate in another psychological treatment at the same time
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple. After the initial screening, 40 people who meet the inclusion criteria and gave informed consent to participate in the study are selected. The Online randomization method is used to create randomization sequences. The randomization unit is an individual, and the GraphpaPad website is the randomization tool. In order to allocation concealment, central randomization method is used. That is, the randomization sequence is provided to the Kolahdooz center, and the researcher, based on the order in which the participants enter the study, communicates with the relevant center and, in the case of the random allocation of the participant, is assigned to the participant. Communication methods include the use of phone or text messages.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2020-02-25, 1398/12/06
Ethics committee reference number
IR.USWR.REC.1399.015
Health conditions studied
1
Description of health condition studied
Anxiety Disorders
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
2
Description of health condition studied
Childhood Trauma
ICD-10 code
F93.9
ICD-10 code description
Childhood emotional disorder, unspecified
Primary outcomes
1
Description
Anxiety level based of Spiel Berger's Inventory (STAI)
Timepoint
Before the intervention, 2 weeks after the intervention, 2 months later in the follow-up
Method of measurement
Spiel Berger's Anxiety Questionnaire (STAI)
Secondary outcomes
1
Description
Depression score
Timepoint
Before the intervention, 2 weeks after the intervention, and 2-month follow-up
Method of measurement
Beck Depression Inventory-II (BDI-II)
2
Description
Posttraumatic Cognitions
Timepoint
Before the intervention, 2 weeks after the intervention, and 2-month follow-up
Before the intervention, 2 weeks after the intervention, and 2-month follow-up
Method of measurement
COPE-brief
4
Description
Emotion Dysregulation
Timepoint
Before the intervention, 2 weeks after the intervention, and 2-month follow-up
Method of measurement
ِDifficulties in Emotion Regulation Scale (DERS-16)
Intervention groups
1
Description
Intervention group: TARGET Group Therapy. TARGET (Trauma Affect Regulation: Guide for Education and Therapy) is one of the new methods of cognitive-behavioral therapy, useful for traumatic disorders. This method trains emotional self-regulation skills for survivors of trauma. This program includes 7 skills, called 7 steps towards FREEDOM, and each of the FREEDOM letters is representative of one skill. According to the group's Manual, the patients participate in 10 sessions (90-minute each session) of emotional self-regulation skills and stress management. These sessions hold once per week.
Category
Treatment - Other
2
Description
Control group: Psychiatric medications. Patients with anxiety disorders who visit a psychiatrist receive their medications depending on the type and severity of the disorder. The most common prescriptions for these patients are Citalopram 20, once per night; Chlorodiazepoxide 10, once per night; S Citalopram 10, once per night; Clonazepam 1, once per night; Gabapentin 100 capsules, consuming in the morning, noon, and at night. The duration of usage, depending on the severity of the disorder and after the control of symptoms, lasts for six months to one year in for stabilization.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Dr. Manteghi
Full name of responsible person
Ali akhoundpour Manteghi
Street address
First Floor, Nikan building, Koohsangi 6, Kouhsangi
City
Mashhad
Province
Razavi Khorasan
Postal code
9174654576
Phone
+98 51 3858 1047
Email
manteghia@mums.ac.ir
2
Recruitment center
Name of recruitment center
Clinic of Dr. Rabbanizadeh
Full name of responsible person
Ali Rabbanizadeh
Street address
First floor, Arman building, 12, Kolahdooz, Ahmadabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9183847169
Phone
+98 51 3842 8684
Email
info@drrabbanizadeh.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khankeh
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0160
Email
hamid.khankeh@ki.se
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Narges Barzgar
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Clinical psychology department, University of social welfare and rehabilitation sciences, koodakyar, daneshjoo blvd, evin, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0045
Fax
Email
Narkises73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Narges Barzgar
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Clinical psychology department, University of social welfare and rehabilitation sciences, koodakyar, daneshjoo blvd, evin, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0045
Fax
Email
Narkises73@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Narges Barzgar
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Clinical psychology department, University of social welfare and rehabilitation sciences, koodakyar, daneshjoo blvd, evin, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0045
Fax
Email
Narkises73@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The sensitivity of trauma and confidentiality of patients' information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available